Actively Recruiting
A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
Led by Mats Heyman · Updated on 2025-09-02
500
Participants Needed
53
Research Sites
717 weeks
Total Duration
On this page
Sponsors
M
Mats Heyman
Lead Sponsor
N
Nordic Society for Pediatric Hematology and Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design. The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study. The study only includes "standard of care" treatment included in the master protocol.
CONDITIONS
Official Title
A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients newly diagnosed with T-lymphoblastic or B-lymphoblastic precursor leukemia (ALL) confirmed by an accredited laboratory at a participating center
- Age from 0 up to (but not including) 46 years at diagnosis
- Patients with surface immunoglobulin negative BCP-ALL and IG::MYC rearrangement unless concurrent BCL2/6 rearrangement is present
- Signed informed consent by patient or legal guardian as per country guidelines
- Diagnosis and treatment at a participating pediatric oncology or adult hematology center
- Resident or intending to settle permanently in a participating country
- Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to treatment start
You will not qualify if you...
- Patients younger than 1 year with KMT2A-rearranged BCP-ALL
- Patients older than 45 years at diagnosis
- Previous malignant diagnosis or relapse of ALL
- Patients with mature B-ALL or IG::MYC with concurrent BCL2/6 rearrangement
- Patients with Philadelphia chromosome-positive ALL
- Known ALL prone syndromes except Down syndrome
- Treatment with systemic corticosteroids (>10mg prednisolone/m2/day) for more than 1 week or chemotherapy within 4 weeks before diagnosis
- Pre-existing contraindications to protocol treatment
- Conditions interfering with study participation or compliance
- Pregnant women of childbearing potential
- Women breastfeeding
- Fertile men and women unwilling to use adequate contraception during therapy
- Essential diagnostic data missing at registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
Aalborg University Hospital, Dept of Paediatrics
Aalborg, Denmark, 9000
Active, Not Recruiting
2
Aarhus University Hospital
Aarhus, Denmark, 8000
Active, Not Recruiting
3
Aarhus University Hospital, Child and Adolescent Health
Aarhus, Denmark, 8200
Active, Not Recruiting
4
Rigshospitalet, Dept of Haematology
Copenhagen, Denmark, 2100
Active, Not Recruiting
5
Rigshospitalet, Dept of Paediatrics
Copenhagen, Denmark, 2100
Active, Not Recruiting
6
Odense University Hospital, Dept of Paediatrics
Odense, Denmark, 5000
Active, Not Recruiting
7
North Estonia Medical Centre, Dept of Haematology
Tallinn, Estonia, 13419
Not Yet Recruiting
8
Tallinn Children´s Hospital, Dept of Paediatrics
Tallinn, Estonia, 13419
Not Yet Recruiting
9
Tartu University Hospital
Tartu, Estonia, 50406
Not Yet Recruiting
10
Helsinki University Hospital, Dept of Haematology
Helsinki, Finland, 00029
Active, Not Recruiting
11
Helsinki University Hospital, Dept of Paediatrics
Helsinki, Finland, 00029
Active, Not Recruiting
12
Kuopio University Hospital, Dept of Haematology
Kuopio, Finland, 70029
Active, Not Recruiting
13
Kuopio University Hospital, Dept of Paediatrics
Kuopio, Finland, 70029
Active, Not Recruiting
14
Oulu University Hospital, Dept of Haematology, Dept of Medicine
Oulu, Finland, 90029
Not Yet Recruiting
15
Oulu University Hospital, Dept of Paediatrics
Oulu, Finland, 90029
Active, Not Recruiting
16
Tampere University Hospital, Dept of Haematology
Tampere, Finland, 33521
Not Yet Recruiting
17
Tampere University Hospital, Dept of Paediatrics
Tampere, Finland, 33521
Active, Not Recruiting
18
Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit
Turku, Finland, 20520
Not Yet Recruiting
19
Turku University Hospital, Dept of Paediatrics
Turku, Finland, 20520
Active, Not Recruiting
20
Landspitali University Hospital, Children's Hospital
Reykjavik, Iceland, 101
Active, Not Recruiting
21
Children's Hospital, Affiliate of Vilnius University Hospital
Vilnius, Lithuania, 08406
Active, Not Recruiting
22
Vilnius University Hospital
Vilnius, Lithuania, 08661
Active, Not Recruiting
23
Haukeland University Hospital, Dept of Haematology
Bergen, Norway, 5021
Active, Not Recruiting
24
Haukeland University Hospital, Dept of Paediatrics
Bergen, Norway, 5021
Active, Not Recruiting
25
Oslo University Hospital, Dept of Haematology
Oslo, Norway, 0372
Active, Not Recruiting
26
Oslo University Hospital, Dept of paediatric haemato- and oncology
Oslo, Norway, 0424
Active, Not Recruiting
27
Stavanger University Hospital, Dept of Haematology
Stavanger, Norway, 4011
Active, Not Recruiting
28
University Hospital North Norway, Dept of Haematology
Tromsø, Norway, 9019
Active, Not Recruiting
29
University Hospital of North Norway, Dept of Paediatrics
Tromsø, Norway, 9038
Active, Not Recruiting
30
St. Olavs University Hospital, Dept of Paediatrics
Trondheim, Norway, 7006
Active, Not Recruiting
31
St. Olavs University Hospital, Dept of Haematology
Trondheim, Norway, 7030
Active, Not Recruiting
32
Hospital Universitario de Cruces
Barakaldo, Spain
Actively Recruiting
33
Hospital Universitario San Joan de Déu
Barcelona, Spain
Actively Recruiting
34
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Actively Recruiting
35
Hospital Universitario La Paz
Fuencarral-El Pardo, Spain
Actively Recruiting
36
Hospital Infantil Universitario Nino Jesus
Madrid, Spain
Actively Recruiting
37
Hospital Universitario Son Espases
Palma de Mallorca, Spain
Actively Recruiting
38
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
39
Hospital Universitario Politécnico La Fe
Valencia, Spain
Actively Recruiting
40
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
41
Sahlgrenska University Hospital, Section for Haematology and coagulation
Gothenburg, Sweden, 41345
Active, Not Recruiting
42
Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology
Gothenburg, Sweden, 41685
Active, Not Recruiting
43
Linköping University Hospital, Dept of Haematology
Linköping, Sweden, 58185
Active, Not Recruiting
44
Linköping University Hospital, Dept of Paediatrics
Linköping, Sweden, 58185
Active, Not Recruiting
45
Skåne University Hospital, Dept of Haematology
Lund, Sweden, 22185
Active, Not Recruiting
46
Skåne University Hospital, Dept of Paediatrics
Lund, Sweden, 22185
Active, Not Recruiting
47
Örebro University Hospital, Section for Haematology
Örebro, Sweden, 70185
Active, Not Recruiting
48
Karolinska University Hospital, Dept of Paediatric Oncology and Haematology
Stockholm, Sweden, 17176
Active, Not Recruiting
49
Karolinska University Hospital, Patient area Haematology
Stockholm, Sweden, 17176
Active, Not Recruiting
50
Norrland University Hospital, Dept of Haematology
Umeå, Sweden, 90185
Active, Not Recruiting
51
Norrland University Hospital, Dept of Paediatrics
Umeå, Sweden, 90185
Active, Not Recruiting
52
Uppsala University Hospital, Dept of Haematology
Uppsala, Sweden, 75185
Active, Not Recruiting
53
Uppsala University Hospital, Dept of Paediatric Haematology and Oncology
Uppsala, Sweden, 75185
Active, Not Recruiting
Research Team
T
Trial Central Office
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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